FDA to consider approval of modified salmon

WASHINGTON — Federal food regulators pondered Monday whether to say, for the first time, that it’s OK to market a genetically engineered animal as safe for people to eat.

The Food and Drug Administration is holding two days of hearings on a request to market genetically modified salmon. Ron Stotish, CEO of AquaBounty, the Massachusetts company that made the marketing request, said at the meeting Monday that his company’s fish product is safe and environmentally sustainable.

Critics, however, call the modified salmon “frankenfish” that could cause allergies in humans and the eventual decimation of the wild salmon population. An FDA advisory committee is reviewing the science of the genetically engineered fish this week and hearing such criticisms as the agency ponders approval.

The FDA has already said that the salmon, which grows twice as fast as its conventional “sisters,” is as safe to eat as the traditional variety.

Whether the public will have an appetite for it is another matter. Genetic engineering is already widely used for crops, but the government until now has not considered allowing the consumption of modified animals. Although the potential benefits — and profits — are huge, many individuals have qualms about manipulating the genetic code of other living creatures.

Part of the two-day hearing will focus on labeling of the fish. It is possible that if the modified salmon is approved, consumers would not even know they were eating it. Current FDA regulations only require modified foods to be labeled as such if the food is substantially different than the conventional version, and the agency has said that the modified salmon is essentially the same as the Atlantic salmon.

Approval of the salmon would open the door for a variety of other genetically engineered animals, including an environmentally friendly pig that is being developed in Canada or cattle that are resistant to mad cow disease.

“For future applications out there the sky’s the limit,” said David Edwards of the Biotechnology Industry Association. “If you can imagine it, scientists can try to do it.”

AquaBounty submitted its first application for FDA approval in 1995, but the agency did not decide until two years ago to consider applications for genetically engineered animals — a move seen as a breakthrough by the biotechnology industry.

Genetically engineered — or GE — animals are not clones, which the FDA has already said are safe to eat. Clones are copies of an animal. With GE animals, their DNA has been altered to produce a desirable characteristic.

In the case of the salmon, AquaBounty has added a growth hormone from a Chinook salmon that allows the fish to produce their growth hormone all year long. The engineers were able to keep the hormone active by using another gene from an eel-like fish called an ocean pout that acts like an on switch for the hormone, according to the company. Conventional salmon only produce the growth hormone some of the time.

In documents released ahead of the hearing, the FDA said there were no biologically relevant differences between the engineered salmon and conventional salmon, and there is a reasonable certainty of no harm from its consumption. FDA scientists speaking Monday said there are very few differences between the modified and conventional fish.

Critics have two main concerns: The safety of the food to humans and the salmon’s effect on the environment.

Because the altered fish has never been eaten before, they say, it could include dangerous allergens, especially because seafood is highly allergenic. They also worry that the fish will escape and intermingle with the wild salmon population, which is already endangered.They would grow fast and consume more food to the detriment of the conventional wild salmon, the critics fear.

A wide range of environmental, food safety and consumer groups have argued that more public studies are needed and the current FDA process is inadequate because it allows the company to keep some proprietary information private. Modified foods are regulated under the same process used for animal drugs.

“It is outrageous to keep this vital information secret,” said Wenonah Hauter, director of the advocacy group Food & Water Watch. “Consumers have a right to know what FDA is trying to allow into our food supply.”

Dr. Michael Hansen, senior scientist at Consumers Union, the publisher of Consumer Reports, says the agency is relying on too little data, much of which is supplied by the company itself.

Stotish countered that the company has more than addressed the concerns, and his product has come under much more scrutiny than most food.

“This is perhaps the most studied fish in history,” he said. “Environmentally this is a very sustainable technology.”

The company has several safeguards in place to allay concerns. All the fish would be bred female and sterile, though a small percentage may be able to breed. They would be bred in confined pools where the potential for escape would be very low.

In its environmental analysis of the fish released earlier this month, the FDA agreed with the company that there are enough safeguards in place.

Stotish says the fish would be bred in better conditions than many of the world’s farmed salmon, and could be located closer to population centers to help feed more people. The company has also said the increase in engineered salmon production could help relieve endangered wild salmon populations.

The company is also arguing that the fish do not need to be labeled as genetically engineered, so the average customer would not know if they were eating the modified product or the conventional product.

“This fish is identical to the traditional food,” maintained Stotish. “The label could even be misleading because it implies a difference that doesn’t exist.”

If approved, the fish could be in grocery stores in two years, the company estimates.